**Executive Summary**
This document details the progress and implementation of the Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices. It announces the introduction of a new Category-B of eligible projects with revised, lower minimum threshold sales criteria in 2023, along with three further rounds of applications. The scheme is scheduled to close in March 2027. It also touches on the CDSCO's regulatory role and the PRIP scheme.
**Key Points / Main Content**
* **PLI Scheme Progress:**
* Annexure A provides details of progress under the PLI scheme, including approved projects, locations, products, and investments.
* Annexure B reports total employment generated and export values under approved projects.
* **New Category-B & Application Rounds:**
* A new Category-B has been introduced with lower minimum threshold sales criteria to encourage wider participation.
* Three additional application rounds have been invited.
* No further rounds of applications will be considered, as the scheme closes in March 2027 with a one-year gestation period.
* **PRIP Scheme:**
* The Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme provides financial assistance for research and innovation, including novel medical devices.
* Assistance can be used for clinical safety and performance validation for regulatory compliance.
* A center of excellence focused on medical devices has been established at the National Institute of Pharmaceutical Education and Research, Ahmedabad, with a ₹ 110 crore outlay.
* **CDSCO Regulations:**
* The Central Drugs Standard Control Organisation (CDSCO) regulates medical device quality, safety, and performance under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.
* An online portal facilitates license and permission granting.
* Rules prescribe licensing timelines.
* Guidance documents, FAQs, tool tips, and an updated medical device classification list are published on the CDSCO website.
* CDSCO is an affiliated member of the International Medical Device Regulators Forum.
* **Industry Development:**
* Various schemes (Medical Device Parks, Strengthening of Medical Device Industry, PLI, and PRIP) aim to enhance the domestic medical device industry's competitiveness.
* These schemes support ecosystem creation, capital expenditure, and research/innovation.
**Impact Analysis**
**Stakeholder: Medical Device Manufacturers (especially MSMEs and startups)**
* **Impact:** Benefit from financial assistance, mentorship, and a more supportive regulatory environment.
* **Action Required:** Explore the PRIP scheme for research and innovation projects, utilize the online CDSCO portal, and consider applying for the PLI scheme before the March 2027 deadline.
**Stakeholder: Investors**
* **Impact:** Informed about investment opportunities in the domestic medical device industry due to the PLI scheme and associated support mechanisms.
* **Action Required:** Analyze Annexure A and B to assess potential investment targets.
**Stakeholder: Department of Pharmaceuticals**
* **Impact:** Responsible for the successful implementation and monitoring of the PLI and PRIP schemes.
* **Action Required:** Continue to promote the schemes, monitor progress against stated objectives, and ensure effective regulatory oversight.
**Stakeholder: CDSCO**
* **Impact:** Plays a vital role in regulating the medical device industry and ensuring compliance.
* **Action Required:** Maintain the online portal, update guidance documents, and process license applications efficiently, adhering to prescribed timelines.
Key Entities Referenced
Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices: The central focus of the policy; provides incentives for domestic manufacturing of medical devices.
Department of Pharmaceuticals: The department under the Ministry of Chemicals and Fertilizers responsible for the PLI scheme and PRIP scheme.
Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme: A scheme to provide financial assistance for research and innovation projects related to medical devices.
Drugs and Cosmetics Act, 1940: Governing law for the regulation of medical devices regarding quality, safety, and performance.
Central Drugs Standard Control Organisation (CDSCO): The regulator of medical devices, responsible for quality, safety and performance.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Progress and implementation of the PLI scheme
for medical devices
प्रव तथ: 16 DEC 2025 3:35PM by PIB Delhi
Details of the progress achieved under the Production Linked Incentive (PLI) Scheme for Promoting
Domestic Manufacturing of Medical Devices since its launch, including the list of projects approved, their
respective locations, products manufactured and investments made, is at Annexure A.
Total employment generated and the value of exports done under the projects approved under the scheme,
as per the report is at Annexure B.
The minimum threshold sales criteria under the scheme have been reviewed and a new Category-B of
eligible projects, with revised minimum threshold sales criteria that are lower, has been introduced in
2023, with a view to encourage wider participation, following which three further rounds of application
have been invited, raising the total number of round of application to file. Since the scheme closes in
March 2027 and provides for a gestation period of one year, no further rounds of application are under
consideration.
The Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme has been launched
to provide financial assistance for eligible research and innovation projects of industries, MSMEs and
startups in identified priority areas, including novel medical devices. Such assistance may also be utilised
towards validation of clinical safety and performance for regulatory compliance. In addition, under the
scheme, a centre of excellence focussed on medical devices has been set up at the National Institute of
Pharmaceutical Education and Research, Ahmedabad, with an outlay of ₹ 110 crore. Moreover, industry
and startups may also take advantage of mentorship support available under various relevant initiatives,
such as the MedTech Mitra and Patent Mitra initiatives of the Department of Health Research,
Government of India.
As per information received from the Department of Health and Family Welfare, the Central Drugs
Standard Control Organisation (CDSCO) regulates quality, safety and performance of medical devices
under the provisions of the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017 made
thereunder. An online portal has been created to facilitate the granting of various licenses and permissions
under the said rules, ensuring greater transparency and accountability in the licensing process. The rules
also prescribe timelines for licensing, with the view to ensure timely processing of applications received
by the licensing authority. In addition, various guidance documents, frequently asked questions, tool tips
and updated classification list of medical devices have been published by CDSCO on its website, with aview to offer greater clarity regarding the regulatory system. Moreover, with a view to foster international
harmonisation, CDSCO has also become an affiliated member of the International Medical Device
Regulators Forum.
The Scheme for Promotion of Medical Device Parks, Strengthening of Medical Device Industry scheme,
PLI Scheme for Promoting Domestic Manufacturing of Medical Devices and PRIP Scheme, launched by
the Department of Pharmaceuticals, are all aimed at making the domestic medical device industry more
competitive, by supporting the creation of an enabling ecosystem for the medical device industry,
incentivising capital expenditure for domestic manufacturing and supporting research and innovation.
Annexure A
Details of the progress achieved under the PLI Scheme for Promoting Domestic Manufacturing of
Medical Devices since its launch
S. No. Applicant Product(s) Investment Address
made till
September
2025
(crore ₹)
1 Panacea Medical Linear accelerator 28.97 Plot No. 35, 4th Phase,
Technologies (LINAC); rotational cobalt KIADB Industrial Area,
Pvt. Ltd. machine Malur, Kolar – 563 130
2 Allengers CT scan; X-ray equipment; 17.75 Khasra No. 168 to 184,
Medical mammography; C-arm; Mukandpur, Derabassi,
Systems Limited cath lab Mohali, Punjab - 140 507
3 BPL Medical Surgical X-ray C-arm; 11.75 Survey No. 27, 2nd Main,
Technologies fixed LF and HF X-ray Jigani Industrial Area,
Pvt. Ltd. products; X-ray panels Anekal Taluk, Bangalore
4 Philips Global MRI coils 112.50 B-78 & B-79, Chakan
Business Industrial Area, Phase II,
Services LLP Village Sawardari
Bhamboli, Taluka Khed,
Pune – 410 510
5 Siemens CT scan; MRI 143.50 Plot No. 16, Survey No.
Healthcare Pvt. 42-P, Electronic City
Ltd. Phase II, Industrial Area,
Hosur Road, Bengaluru,
Karnataka -560 1006 Trivitron X-ray equipment; C-arm; 11.30 Plot No. A-16, Patalganga
Healthcare Pvt. mammography; Industrial Area, Village
Ltd. ultrasonography Kaire, Rasayani, Raigad,
Maharashtra – 410 220
MU-H, AMTZ Campus,
Pragati Maidan,
Visakhapatnam – 530 031
7 Wipro GE CT scan; cath lab; 57.29 No. 4 Kadugodi Industrial
Healthcare Pvt. ultrasonography Area, Bangalore,
Ltd. Karnataka – 560 067
8 Allied Medical Anaesthesia workstation; 14.50 Plot No. F-126 & 127, G-
Limited anaesthesia unit gas 133 & 134, Industrial
scavengers; anaesthesia Area, Karoli, Alwar – 301
kits; masks —anaesthesia; 019
anaesthesia unit vaporisers;
anaesthesia unit ventilators;
automated external
defibrillators (AEDs); bi-
phasic defibrillators,;
infusion pumps — syringe
and volumetric; intensive
care ventilators; emergency
ventilators (portable
ventilators); high flow
oxygen devices; multi-
parameter monitor; suction
machine
9 BPL Medical Patient monitoring; 9.90 Survey No. 27, 2nd Main,
Technologies automated external Jigani Industrial Area,
Pvt. Ltd. defibrillators (AEDs); Anekal Taluk, Bangalore
ECG; stress test system
10 Deck Mount Oxygen concentrator 8.00 260 Udyog Vihar, Phase
Electronics 4, Gurugram, Haryana
Limited
11 Microtek New Oxygen concentrators 13.58 Village Kattha, Baddi,
Technologies Distt. Solan, Himachal
Pvt. Ltd. Pradesh – 173 20512 Nipro India Dialyser 216.87 Plot No E-1/1, MIDC
Corporation Pvt. Kesurdi, Taluka
Ltd. Khandala, Satara,
Maharashtra – 412 802
13 Poly Medicure Dialyser; dialysis machine; 48.96 Plot No. 34 Sec 68 IMT
Limited peritoneal dialysis kits; Faridabad
fistula; blood line;
haemodialysis catheter;
transducer protector
14 Envision Stents; PTCA balloon 50.98 Plot No. 177, 178, 201 &
Scientific Pvt. catheter 202, Surat Special
Ltd. Economic Zone, Sachin,
Surat – 394 230
15 Innvolution Stents 21.77 Plot No. 105, Solitaire
Healthcare Pvt. Industrial Park, Dehmi
Ltd. Kalan, Sanganer, Jaipur –
302 026
PTCA catheter AMTZ Campus, Pragati
Maidan, V M Steel
Project S.O.,
Visakhapatnam – 530 031
16 Meril Healthcare Hip implants; knee implant; 90.49 Bilakhia House,
Pvt. Ltd. trauma implant Muktanand Marg, Chala
Vapi, Gujarat - 396 191
17 Meril Life Heart valves; stents; PTCA 48.59 Bilakhia House,
Sciences Pvt. ballon catheter Muktanand Marg, Chala
Ltd. Vapi, Gujarat – 396 191
18 Motherson — 53.48 Plot No.41 & 50, Sojitz
Health and Motherson Industrial
Medical System Park, Singadivakkam
Limited Village & Panchayat,
Kanchipuram Taluk &
District, Tamil Nadu –
631 56119 Omron — 19.93 Mahindra Origins, Plot
Healthcare Nos. I-22, 23 and 24
Manufacturing (9.358 Acres)
India Pvt. Ltd. Eliyambedu Village,
Peruvoyal Revenue
Village, Gummidipoondi
Taluk, Thiruvallur
District, Tamil Nadu –
601 206
20 Meril Endo Hernia surgical mesh 11.62 Bilakhia House,
Surgery Pvt. implants other products; Muktanand Marg, Chala,
Ltd. endocutter; linear stapler; Vapi – 396 191
linear cutter; trocar;
litigation clip; hemostates
21 Majik Medical Catheter tubing 28.62 Plot No. M 46, Medical
Solutions Pvt. (cardiovascular); Device Park, Sultanpur,
Ltd. micro-catheter tubing Patancheru, Hyderabad,
(neurovascular) Telangana - 502 319
22 Varex Imaging — 42.19 Plot No. B4, Talegaon
Manufacturing Industrial Plot, PH -II,
India Pvt. Ltd. Village-Badhalwadi,
Taluka-Maval, District-
Pune, Maharashtra
23 Syrma Johari — 3.57 G-582-584, EPIP
Medtech Boranada, Jodhpur,
Limited Rajasthan – 342 013
24 Syrma Johari — 3.75 G-582-584, EPIP
Medtech Boranada, Jodhpur,
Limited Rajasthan – 342 014
25 GE BE Pvt. Ltd. PET detector 5.98 60, Export Promotion,
Industrial Park,
Whitefield, Bengaluru,
Karnataka – 560 066
26 Meril Medical Laser ablation system 0.20 F2, F3 & F5, Survey No.
Innovations Pvt. 879, Muktanand Marg,
Ltd. Chala, Vapi, Valsad,
Gujarat – 396 19127 Meril Medical Intravascular lithotripsy 1.33 F2, F3 & F5, Survey No.
Innovations Pvt. catheter system 879, Muktanand Marg,
Ltd. Chala, Vapi, Valsad,
Gujarat – 396 191
28 Varex Imaging Digital X-ray flat panel 16.32 Plot No. C2-154 / C2-
Manufacturing detector 155, Andhra Pradesh
India Pvt. Ltd. Medtech Zone (AMTZ)
Limited, PTA No.
1086509931, Old
Revenue Ward No. 54,
New Revenue Ward No.
77, Zone VI of GVMC
comprised in Survey No.
480/2, Nadupuru,
Pedagantyada Mandal,
Visakhapatnam District,
Andhra Pradesh - 530 031
Annexure B
Total employment generated and the value of exports under the projects
S. Selected beneficiary Cumulative Employment till
No. exports till September 2025
September 2025
(crore ₹)
1 Allengers Medical Systems Ltd. 152.75 537
2 Allied Medical Ltd. 31.80 191
3 BPL Medical Technologies Pvt. Ltd. 2.66 87
4 BPL Medical Technologies Pvt. Ltd. 3.38 86
5 Deck Mount Electronics Ltd. 0.00 —
6 Envision Scientific Pvt. Ltd. 161.10 180
7 GE BE Pvt. Ltd. 20.83 19
8 Innvolution Healthcare Pvt. Ltd. 0.00 2289 Syrma Johari Medtech Ltd. 0.00 —
10 Syrma Johari Medtech Ltd. 0.00 —
11 Majik Medical Solutions Pvt Ltd 43.23 243
12 Meril Endo Surgery Pvt. Ltd. 1.32 108
13 Meril Healthcare Pvt. Ltd. 564.46 995
14 Meril Life Sciences Pvt. Ltd. 1634.36 451
15 Meril Medical Innovations Pvt. Ltd. 0.00 8
16 Meril Medical Innovations Pvt. Ltd. 0.00 47
17 Microtek New Technologies Pvt. Ltd. 0.00 1
18 Nipro India Corporation Pvt. Ltd. 902.16 368
19 Omron Healthcare Manufacturing India Pvt. Ltd. 0.00 21
20 Panacea Medical Technologies Pvt. Ltd. 36.30 446
21 Philips Global Business Services LLP 2187.45 364
22 Poly Medicure Ltd. 10.99 740
23 Motherson Health and Medical System Ltd. 0.00 129
24 Siemens Healthcare Pvt. Ltd. 0.00 15
25 Trivitron Healthcare Pvt. Ltd. 15.27 51
26 Varex Imaging Manufacturing India Pvt. Ltd. (R-III) 0.00 —
27 Varex Imaging Manufacturing India Pvt. Ltd. (R-IV) 0.00 —
28 Wipro GE Healthcare Pvt. Ltd. 101.30 86
This information was given by Union Minister of State in the Ministry of Chemicals and Fertilizers, Smt.
Anupriya Patel, in a written reply in Rajya Sabha today.*****
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